Evidence map›Paper›PMID 39495339›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2024

Concordance of patient- and clinician-reported outcomes of acute radiation dermatitis in breast cancer.

Milena Gojsevic, Thenugaa Rajeswaran, Liying Zhang, Samantha K F Kennedy, Irene Karam, Keyue Ding, Patries Herst, Henry Wong, Jennifer Y Y Kwan, Amir H Safavi and 8 more

Abstract readMulticenter StudyRandomized Controlled TrialClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

18 authors.

Milena GojsevicOdette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Thenugaa RajeswaranOdette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Liying ZhangMacroStat Inc, Toronto, ON, Canada.
Samantha K F KennedyOdette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Irene KaramOdette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Keyue DingCanadian Cancer Trials Division, Queen's Cancer Research Institute, Queen's University, Kingston, ON, Canada.
Patries HerstDepartment of Radiation Therapy, University of Otago, Wellington, New Zealand.
Henry WongDepartment of Oncology, Princess Margaret Hospital, Hong Kong, Hong Kong.
Jennifer Y Y KwanRadiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Canada.
Amir H SafaviOdette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Jacqueline LamDepartment of Radiation Oncology, Health Sciences North, Sudbury, ON, Canada.
Silvana SpadaforaDepartment of Radiation Oncology, Sault Area Hospital, Sault Ste. Marie, ON, Canada.
Natalie WaldeDepartment of Radiation Oncology, Sault Area Hospital, Sault Ste. Marie, ON, Canada.
Katherine CarothersOdette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Francois GallantOdette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Tara BehroozianMichael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
Emily LamOdette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Edward ChowDepartment of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada. edward.chow@sunnybrook.ca.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeThe study evaluated the concordance between patient-reported outcomes (PRO) and clinician-reported outcomes (CRO) of acute radiation dermatitis (RD) symptoms following adjuvant radiotherapy for early-stage and locally advanced breast cancer. MATERIAL AND

methodsThis is a secondary analysis of a multi-center randomized phase 3 trial (376 patients). Ordinal logistic regression analysis was used to compare the Skin Symptom Assessment (SSA) independently reported by both patients and clinicians. Concordance between patient- and clinician-reported SSAs for RD symptoms was measured by percent concordance, concordance index (C-statistic), and Cohen's Kappa. Analyses were performed across all patients in the original modified intention-to-treat analysis and those with only grade 2-3 (CTCAE) RD.

resultsPROs were significantly more severe than CROs across all RD symptoms (Odds Ratio [OR] > 1; p < 0.0001). Pigmentation (OR 5.4), blistering/peeling (OR 4.0), and pain/soreness (OR 3.9) were the most differentially reported symptoms. Poor-to-low concordance was noted between patient- and clinician-reported SSAs for all RD symptoms for the entire cohort (percent concordance < 50%, C-statistic 0.52-0.63, Cohen's Kappa 13.9-23.4%) and those with grade 2-3 RD (percent concordance < 50%, C-statistic 0.56-0.66, Cohen's Kappa 2.0-24.5%). Similarly, poor-to-low concordance was noted in both Mepitel film and standard-of-care arms.

conclusionPROs and CROs have poor concordance in breast RD, and patients report worse outcomes than clinicians, regardless of RD severity or prophylaxis. PROs must be further integrated into routine clinical practice and clinical trial design to reduce the risk of underreporting symptoms.

Indexed as

Breast NeoplasmsPatient Reported Outcome MeasuresRadiodermatitisAcute DiseaseAdultAgedFemaleHumansLogistic ModelsMiddle AgedRadiotherapy, AdjuvantSeverity of Illness IndexBreast cancerMepitel filmPatient-reported outcomeRadiation dermatitisSkin toxicity

Identifiers

PMID39495339

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.